PSC Biotech provides the life sciences with essential services to ensure that health care products are developed manufactured and distributed to the highest standards in compliance with all applicable regulatory requirements.
Our goal is to skyrocket our clients success and you can be a part of our teams achievements. Employing a global team of skilled professionals and experts that span across strategically located offices in North America Europe Asia and the Middle East we are proud of the roles we have fulfilled to help our clients achieve success.
The Experience
With operations spanning the globe and featuring a multi-cultural team PSC Biotech is passionate about bringing the best and brightest together to form something truly special. When you make the decision to join our team you will be offered the ability to feel inspired in your career explore your professional passions and work alongside a group of people who will value and nurture your talents.
We are firm believers in coaching and developing the next generation of industry leaders and influencers. As such you will not only be offered compensation and benefits structure that rewards you but also be provided with the tools that will help you grow and learn.
At PSC Biotech its about more than just a jobits about your career and your future.
Your Role
We are hiring an experienced Qualification Engineer to support facility qualification and environmental testing activities to ensure compliance with GMP Annex 1 and ISO standards. This role is responsible for leading the coordination and execution of testing activities clean-room qualifications contamination control strategy and protocol writing.
- Oversee the planning coordination and execution of room qualification testing ensuring alignment with production schedules and regulatory requirements.
- Schedule and coordinate dynamic room qualification testing (airflow pressure differentials particle counts recovery HEPA integrity etc.) ensuring personnel environmental conditions and signage comply with regulatory requirements. Ensure entry/exit control and gowning compliance during testing.
- Write and review qualification protocols (IQ OQ PQ) operating procedures and required reports in accordance with GMP and internal procedures.
- Identify any deviations and out-of-spec results assist in determining root cause and support corrective actions.
- Collaborate closely with cross functional teams including manufacturing facilities quality and validation departments to schedule qualification and testing activities with minimal production disruption.
- Ensure adherence to Annex 1 requirements site SOPs and contamination control strategies at all times.
- Additional responsibilities as required.
Requirements
- Bachelors degree in a scientific engineering or technical discipline.
- 5-10 years of experience in GMP regulated/pharmaceutical facility qualification and environmental testing.
- Advanced knowledge of GMP Annex 1 ISO regulations/standards and aseptic/sterile processes.
- Hands-on experience with clean room testing such as particle counting airflow visualization pressure differential mapping filter integrity testing etc.
- Well-versed in GMP documentation and quality systems.
- Detail oriented with focus on regulatory compliance and accuracy.
- Demonstrated ability to lead testing teams and coordinate activities across departments
- Strong understanding of room readiness and signage requirements.
- Proficiency with testing tools and procedures such as Climet particle counters HEPA filter integrity testing equipment and EMS systems.
- Strong organizational skills with the ability to manage schedules personnel and documentation simultaneously.
- Excellent communication and collaboration skills.
- Strong analytical and problem-solving skills.
- At PSC Biotech many of our projects and clients are located in various regions around the country. Therefore we value candidates who are willing and able to travel as needed for project assignments and client engagements. The ability to adapt to different locations cultures and work environments is essential as it allows our team members to collaborate effectively with clients and colleagues nationally.
- Must be authorized to work in the US.
- No C2C at this time.
Benefits
Offering a full suite of benefits PSC Biotech is firmly focused on diligently investing in our employees who enable our company to fulfill our mission and achieve success. We want to promote balance so you not only enjoy your work but also have the time and resources to live your life happy and healthy.
- Medical Dental and Vision - PSC pays 100% of all qualifying employee medical premiums and 50% for qualifying dependents
- Insurance options for Employee Assistance Programs Basic Life Insurance Short/Long Term Disability and more.
- 401(k) and 401(k) matching
- PTO Sick Time and Paid Holidays
- Education Assistance
- Pet Insurance
- Discounted rate at Anytime Fitness
- Financial Perks and Discounts
Adhering to the requirements of Californias law on salary transparency the salary bracket for this role is set between $90000 - $115000 annually. The salary offered may be adjusted based on various factors such as the applicants qualifications skills and professional experience.
Equal Opportunity Employment Statement
PSC is committed to is committed to a policy of Equal Employment Opportunity with respect to all employees interns and applicants for employment. Consistent with this commitment our policy is to comply with all applicable federal state and local laws concerning employment discrimination. Accordingly the company prohibits discrimination against qualified employees interns and applicants in all aspects of employment including but not limited to: recruitment interviewing hiring (or failure or refusal to hire) evaluation compensation promotion job assignment transfer demotion training leaves of absence layoff benefits use of facilities working conditions termination and employer-sponsored activities and programs including wellness social and recreational programs. Employment decisions will be made without regard to an applicants employees or interns actual or perceived: race color religion sex (including pregnancy gender identity and sexual orientation) national origin age (40 or older) disability genetic information or any other status protected by law.
#LI-RD1
Required Skills:
Bachelors degree in a scientific engineering or technical discipline. 5-10 years of experience in GMP regulated/pharmaceutical facility qualification and environmental testing. Advanced knowledge of GMP Annex 1 ISO regulations/standards and aseptic/sterile processes. Hands-on experience with clean room testing such as particle counting airflow visualization pressure differential mapping filter integrity testing etc. Well-versed in GMP documentation and quality systems. Detail oriented with focus on regulatory compliance and accuracy. Demonstrated ability to lead testing teams and coordinate activities across departments Strong understanding of room readiness and signage requirements. Proficiency with testing tools and procedures such as Climet particle counters HEPA filter integrity testing equipment and EMS systems. Strong organizational skills with the ability to manage schedules personnel and documentation simultaneously. Excellent communication and collaboration skills. Strong analytical and problem-solving skills. At PSC Biotech many of our projects and clients are located in various regions around the country. Therefore we value candidates who are willing and able to travel as needed for project assignments and client engagements. The ability to adapt to different locations cultures and work environments is essential as it allows our team members to collaborate effectively with clients and colleagues nationally. Must be authorized to work in the US. No C2C at this time.
PSC Biotech provides the life sciences with essential services to ensure that health care products are developed manufactured and distributed to the highest standards in compliance with all applicable regulatory requirements. Our goal is to skyrocket our clients success and you can be a part of our ...
PSC Biotech provides the life sciences with essential services to ensure that health care products are developed manufactured and distributed to the highest standards in compliance with all applicable regulatory requirements.
Our goal is to skyrocket our clients success and you can be a part of our teams achievements. Employing a global team of skilled professionals and experts that span across strategically located offices in North America Europe Asia and the Middle East we are proud of the roles we have fulfilled to help our clients achieve success.
The Experience
With operations spanning the globe and featuring a multi-cultural team PSC Biotech is passionate about bringing the best and brightest together to form something truly special. When you make the decision to join our team you will be offered the ability to feel inspired in your career explore your professional passions and work alongside a group of people who will value and nurture your talents.
We are firm believers in coaching and developing the next generation of industry leaders and influencers. As such you will not only be offered compensation and benefits structure that rewards you but also be provided with the tools that will help you grow and learn.
At PSC Biotech its about more than just a jobits about your career and your future.
Your Role
We are hiring an experienced Qualification Engineer to support facility qualification and environmental testing activities to ensure compliance with GMP Annex 1 and ISO standards. This role is responsible for leading the coordination and execution of testing activities clean-room qualifications contamination control strategy and protocol writing.
- Oversee the planning coordination and execution of room qualification testing ensuring alignment with production schedules and regulatory requirements.
- Schedule and coordinate dynamic room qualification testing (airflow pressure differentials particle counts recovery HEPA integrity etc.) ensuring personnel environmental conditions and signage comply with regulatory requirements. Ensure entry/exit control and gowning compliance during testing.
- Write and review qualification protocols (IQ OQ PQ) operating procedures and required reports in accordance with GMP and internal procedures.
- Identify any deviations and out-of-spec results assist in determining root cause and support corrective actions.
- Collaborate closely with cross functional teams including manufacturing facilities quality and validation departments to schedule qualification and testing activities with minimal production disruption.
- Ensure adherence to Annex 1 requirements site SOPs and contamination control strategies at all times.
- Additional responsibilities as required.
Requirements
- Bachelors degree in a scientific engineering or technical discipline.
- 5-10 years of experience in GMP regulated/pharmaceutical facility qualification and environmental testing.
- Advanced knowledge of GMP Annex 1 ISO regulations/standards and aseptic/sterile processes.
- Hands-on experience with clean room testing such as particle counting airflow visualization pressure differential mapping filter integrity testing etc.
- Well-versed in GMP documentation and quality systems.
- Detail oriented with focus on regulatory compliance and accuracy.
- Demonstrated ability to lead testing teams and coordinate activities across departments
- Strong understanding of room readiness and signage requirements.
- Proficiency with testing tools and procedures such as Climet particle counters HEPA filter integrity testing equipment and EMS systems.
- Strong organizational skills with the ability to manage schedules personnel and documentation simultaneously.
- Excellent communication and collaboration skills.
- Strong analytical and problem-solving skills.
- At PSC Biotech many of our projects and clients are located in various regions around the country. Therefore we value candidates who are willing and able to travel as needed for project assignments and client engagements. The ability to adapt to different locations cultures and work environments is essential as it allows our team members to collaborate effectively with clients and colleagues nationally.
- Must be authorized to work in the US.
- No C2C at this time.
Benefits
Offering a full suite of benefits PSC Biotech is firmly focused on diligently investing in our employees who enable our company to fulfill our mission and achieve success. We want to promote balance so you not only enjoy your work but also have the time and resources to live your life happy and healthy.
- Medical Dental and Vision - PSC pays 100% of all qualifying employee medical premiums and 50% for qualifying dependents
- Insurance options for Employee Assistance Programs Basic Life Insurance Short/Long Term Disability and more.
- 401(k) and 401(k) matching
- PTO Sick Time and Paid Holidays
- Education Assistance
- Pet Insurance
- Discounted rate at Anytime Fitness
- Financial Perks and Discounts
Adhering to the requirements of Californias law on salary transparency the salary bracket for this role is set between $90000 - $115000 annually. The salary offered may be adjusted based on various factors such as the applicants qualifications skills and professional experience.
Equal Opportunity Employment Statement
PSC is committed to is committed to a policy of Equal Employment Opportunity with respect to all employees interns and applicants for employment. Consistent with this commitment our policy is to comply with all applicable federal state and local laws concerning employment discrimination. Accordingly the company prohibits discrimination against qualified employees interns and applicants in all aspects of employment including but not limited to: recruitment interviewing hiring (or failure or refusal to hire) evaluation compensation promotion job assignment transfer demotion training leaves of absence layoff benefits use of facilities working conditions termination and employer-sponsored activities and programs including wellness social and recreational programs. Employment decisions will be made without regard to an applicants employees or interns actual or perceived: race color religion sex (including pregnancy gender identity and sexual orientation) national origin age (40 or older) disability genetic information or any other status protected by law.
#LI-RD1
Required Skills:
Bachelors degree in a scientific engineering or technical discipline. 5-10 years of experience in GMP regulated/pharmaceutical facility qualification and environmental testing. Advanced knowledge of GMP Annex 1 ISO regulations/standards and aseptic/sterile processes. Hands-on experience with clean room testing such as particle counting airflow visualization pressure differential mapping filter integrity testing etc. Well-versed in GMP documentation and quality systems. Detail oriented with focus on regulatory compliance and accuracy. Demonstrated ability to lead testing teams and coordinate activities across departments Strong understanding of room readiness and signage requirements. Proficiency with testing tools and procedures such as Climet particle counters HEPA filter integrity testing equipment and EMS systems. Strong organizational skills with the ability to manage schedules personnel and documentation simultaneously. Excellent communication and collaboration skills. Strong analytical and problem-solving skills. At PSC Biotech many of our projects and clients are located in various regions around the country. Therefore we value candidates who are willing and able to travel as needed for project assignments and client engagements. The ability to adapt to different locations cultures and work environments is essential as it allows our team members to collaborate effectively with clients and colleagues nationally. Must be authorized to work in the US. No C2C at this time.
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Posted on:
30+ days ago
Vacancies:
1 Vacancy
